Acetaminophen and AKI After Aortic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-12-30

Brief Summary

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Acute kidney injury is commonly accompanied major complication after aortic surgery.

Cardipulmonary bypass lyses erythrocyte and induces lipid peroxidation. This increases plasma free hemoglobin, F2-isoprostane, and isofuran concentration. Cell free hemoglobin have been reported to be associated with poor prognosis such as acute kidney injury, myocardial infarction, and death.

Acetaminophen is reported to attenuate hemeprotein mediated lipid peroxidation. Thus, investigators hypothesized that acetaminophen might have protective effect on the incidence of acute kidney injury in patients undergoing aortic surgery with moderate hypothermic circulatory arrest.

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Detailed Description

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Conditions

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Aortic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Acetaminophen group

patients receiving acetaminophen

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Acetaminophen 1g IV every 6 hours for a weight \> 50kg (maximum of 4g per 24 hours) or 15mg/kg every 6 hours for a weight \< 50kg (maximum of 75mg/kg per 24 hours)

Placebo group

patients receiving equal amount of normal saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Normal saline 100 ml (equal amount of acetaminophen) IV every 6 hours

Interventions

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Acetaminophen

Acetaminophen 1g IV every 6 hours for a weight \> 50kg (maximum of 4g per 24 hours) or 15mg/kg every 6 hours for a weight \< 50kg (maximum of 75mg/kg per 24 hours)

Intervention Type DRUG

Placebo

Normal saline 100 ml (equal amount of acetaminophen) IV every 6 hours

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1\) Patients undergoing aortic surgery with moderate hypothermic circulatory arrest.

Exclusion Criteria

1. patients with chronic kidney disease or with dialysis, eGFR \< 15ml/min/1.73m2
2. allergy to acetaminophen or propacetamol HCl
3. history of liver cirrhosis or total bilirubin \> 2.0mg/dL

3\) patients taking acetaminophen or diclofenac 4) patients who cannot understand informed consent

Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No